1. Field of this Invention
This invention relates to a process for testing for the inactivation of vaccines, harmlessness of blood products and effectiveness of chemotherapeutic agents and disinfectants against viral hepatitis, in particular type A and type B, by the determination of antibodies in the animal model. It further relates to a process for the growth and collection of viral hepatitis antigen, particularly type A and type B, from the animal model.
2. Prior Art
In the activation of vaccines, the vaccine is deprived of its power to multiply, while the pathogens retain their antigenicity and thus retain the ability to immunize the vaccinated person. Testing for inactivation is of great importance both with respect to the effectiveness and harmlessness or toxicity of the vaccine. Furthermore, products made from donated blood, e.g., coagulation factors, albumins and globulins, are administered to patients to cure various diseases or as a treatment for circulation problems. To ensure that these materials do not contain any hepatitis viruses, they must first be examined using a suitable animal model. The effectiveness of chemotherapeutic agents, which is decisive for the number and size of doses to be administered and thus in turn affects the patient's tolerance of the preparation, is just as important as the harmlessness of vaccines and blood products.
Disinfectants must be available for work in laboratories, hospitals, etc., in order to be able to destroy any infectious material that might be present. Disinfectant solutions containing formalin are currently used against viral hepatitis, but they have the disadvantage of having a strong smell, and in the case of prolonged action, they involve the possibility of carcinogenesis. Animal models are also necessary to test the effectiveness of new developments in this field.
Currently known animal models for viral hepatitis type A include marmosets and anthropoids of the types S. mystax, S. nigricollis, S. fuscicollis, S. oedipus, Callithrix jacchus, C. argentata, Cercopithecus aethiops, Pantroglodytes and Anthropopithecus troglodytes. For viral hepatitis type B, primates, e.g., chimpanzees, are the only known animal model. All these animal models are too expensive to maintain and some of them are threatened with extinction. In addition, breeding is uneconomic because for example in the case of C. jacchus only four offspring per breeding pair per year at most can be bred. Other more readily available subprimates or primates are not known as animal models for hepatitis viruses.